Food compositions and methods for preventing copper-associated hepatopathies

ABSTRACT

A pet food containing naturally occurring copper that can be used as a prophylactic diet to prevent and/or reduce copper storage disease, dilated cardiomyopathy, adverse gastrointestinal food reactions, and/or food allergies in pets is provided. A method for forming this pet food containing naturally occurring copper includes: providing a formula selected from the group consisting of chicken meal, corn gluten, duck, rabbit, venison, fish, peas, potato, barley, rice, corn, and any combinations thereof; and adding one or more ingredients having a naturally occurring copper source to provide a naturally occurring copper concentration in the pet food composition from about 7.3 ppm to about 25.0 ppm, adjusted for a dry matter basis.

PRIORITY CLAIM

This application is a divisional of U.S. application Ser. No.16/555,588, filed Aug. 29, 2019, and entitled “FOOD COMPOSITIONS ANDMETHODS FOR PREVENTING COPPER-ASSOCIATED HEPATOPATHIES,”, which claimspriority under 35 U.S.C. § 119(e) to U.S. Provisional Patent ApplicationNo. 62/725,817 filed on Aug. 31, 2018. The entire contents of theaforementioned applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to pet foods designed to preventcopper accumulation in livers, and more particularly, to foods andmethods designed to prevent or at least reduce copper storage disease,dilated cardiomyopathy, adverse gastrointestinal food reactions, foodallergies, and any combinations thereof in pets.

BACKGROUND OF THE INVENTION

In the mid-1990's the pet food industry changed the source of copper inpet food from cupric oxide to chelated copper sources such as coppersulfide. The predominately used chelated copper sources used and stillbeing used today are either copper sulfate and/or copper proteinate. Theuse of copper sulfate and/or copper proteinate was driven by two studiesthat were performed on cattle and pigs that demonstrated growth wasfaster on cattle and pigs when cupric oxide was replaced with thesechelated copper sources. Following the lead of the livestock industryand without any extensive testing on domesticated animals including dogsand cats, the Association of American Feed Control Officials (“AAFCO”)announced and required pet food manufacturers to use copper sulfateand/or copper proteinate for copper fortification in their foodproducts.

Accordingly, there is a need to both determine the long and short termeffects of chelated copper sources used in pet food as a means forproviding the proper nutritional supplement for dogs, cats, and thelike. Developing improved diets for pets can lead to a variety ofimproved health benefits including, for example, reduced veterinarybills, better responses to drugs, and a longer more active lifestyleleading to better pet relationships with their caretakers.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, a pet food compositionis provided.

The pet food composition comprises a naturally occurring copperconcentration from about 7.3 ppm to about 25.0 ppm; an omega-6 fattyacid and an omega-3 fatty acid wherein the omega-6 fatty acid to omega-3fatty acid ratio is from about 5:1 to about 10:1; at least one mineralincluding a zinc oxide concentration from about 150 mg/kg to about 1000mg/kg; two or more vitamins including: a vitamin E concentration fromabout 300 iu/kg to about 1000 iu/kg; and a vitamin B6 concentration fromabout 2 mg/kg to about 50 mg/kg. The quantities provided for thecomponents of the pet food composition are calculated on a dry matterbasis.

According to another aspect of the present invention, a method offorming a pet food composition is provided. The method includesproviding a formula selected from the group consisting of chicken, corngluten, fish, venison, ostrich, rabbit, pea, potato, barley, rice, corn,and any combinations thereof; adding one or more ingredients having anaturally occurring copper source to provide a naturally occurringcopper concentration in the pet food composition from about 7.3 ppm toabout 25.0 ppm; adding an omega-6 fatty acid and an omega-3 fatty acidwherein the omega-6 fatty acid to omega-3 fatty acid ratio is from about1:1 to about 10:1; adding at least one mineral including a zinc oxideconcentration from about 150 mg/kg to about 1000 mg/kg; and adding twoor more vitamins including a vitamin E concentration from about 300iu/kg to about 1000 iu/kg and a vitamin B6 concentration from about 2mg/kg to about 50 mg/kg. The quantities provided for the components ofthe pet food composition are calculated on a dry matter basis.

According to a still another aspect of the present invention, a methodof reducing copper accumulation in pets is provided. The method includesproviding a formula selected from the group consisting of chicken, corngluten, fish, venison, ostrich, rabbit, pea, potato, barley, rice, corn,and any combinations thereof; adding one or more ingredients having anaturally occurring copper source to provide a naturally occurringcopper concentration in the pet food composition from about 7.3 ppm toabout 25.0 ppm to form a naturally occurring copper prophylactic petfood; and feeding a pet the naturally occurring copper prophylactic petfood. The method may further include adding an omega-6 fatty acid and anomega-3 fatty acid wherein the omega-6 fatty acid to omega-3 fatty acidratio is from about 1:1 to about 10:1 where the omega-6 and omega-3fatty acids are added to help prevent an arachidonic acid cascade. Themethod may further include adding at least one mineral including a zincoxide concentration from about 150 mg/kg to about 1000 mg/kg where thezinc oxide concentration is added to help prevent copper absorption by agastrointestinal tract. The method may still further include adding atleast one vitamin including a vitamin E concentration from about 300iu/kg to about 1000 iu/kg where the vitamin E concentration is added asan antioxidant to help prevent an arachidonic acid cascade. The methodmay still yet include adding at least one vitamin including a vitamin B6concentration from about 2 mg/kg to about 50 mg/kg where the vitamin B6concentration is added to help prevent cirrhosis in hepatic necrosis.The quantities provided for the components of the pet food compositionare calculated on a dry matter basis.

According to yet another aspect of the present disclosure, a method offorming an AAFCO compliant pet food product or composition containingsubstantially no copper sulfate and/or copper proteinate is provided.The method comprises providing a formula selected from the groupconsisting of chicken, corn gluten, fish, venison, ostrich, rabbit, pea,potato, barley, rice, corn, and any combinations thereof; adding one ormore ingredients having a naturally occurring copper source to provide anaturally occurring copper concentration in the pet food compositionfrom about 7.3 ppm to about 25.0 ppm; adding an omega-6 fatty acid andan omega-3 fatty acid wherein the omega-6 fatty acid to omega-3 fattyacid ratio is from about 1:1 to about 10:1; adding at least one mineralincluding a zinc oxide concentration from about 150 mg/kg to about 1000mg/kg; and adding two or more vitamins including a vitamin Econcentration from about 300 iu/kg to about 1000 iu/kg and a vitamin B6concentration from about 2 mg/kg to about 50 mg/kg to form the AAFCO petfood product or composition. The quantities provided for the componentsof the pet food composition are calculated on a dry matter basis.

According to still another aspect of the present disclosure, a method ofpreventing or at least reducing copper storage disease, dilatedcardiomyopathy, adverse gastrointestinal food reactions, and foodallergies in pets is provided. The method comprises making aprophylactic pet food composition including: a formula selected from thegroup consisting of chicken meal, corn gluten, fish, peas, potato,barley, rice, corn, and any combinations thereof; a naturally occurringcopper concentration from about 7.3 ppm to about 25.0 ppm; at least onemineral including a zinc oxide concentration from about 150 mg/kg toabout 1000 mg/kg; a combination of DL-methionine and taurine; an omega-6fatty acid and an omega-3 fatty acid wherein the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 5:1; two or morevitamins including a vitamin E concentration from about 300 iu/kg toabout 1000 iu/kg and a vitamin B6 concentration from about 2 mg/kg toabout 50 mg/kg; and substantially no beef, substantially no milk, andsubstantially no wheat. The method further comprises feeding the pet theprophylactic pet food composition to prevent or at least reduce the riskof copper storage disease, dilated cardiomyopathy, adversegastrointestinal food reactions, and food allergies in pets. In someaspects, the prophylactic pet food composition is an AAFCO compliantfood product or composition. The quantities provided for the componentsof the pet food composition are calculated on a dry matter basis.

These and other aspects, objects, and features of the present inventionwill be understood and appreciated by those skilled in the art uponstudying the following specification, claims, and appended drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Nearly 70% of all U.S. households own a pet where pet ownerscollectively spend billions of dollars annually on pet care includingveterinary expenses such as wellness checks and parasite control. Petfood can account for nearly 40% of a pet's cost so there exists a highdemand for improved pet food diets that can both improve a pet's healthand reduce other expenses such as veterinary bills.

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Accordingly, the followingterms are intended to have the following meanings:

As used in the specification and claims, the singular form “a”, “an” and“the” includes plural references unless the context clearly dictatesotherwise.

As used herein, “administration” of a disclosed compound encompasses thedelivery to a subject of a compound as described herein, or a prodrug orother pharmaceutically acceptable derivative thereof, using any suitableformulation or route of administration, e.g., as described herein.

As used herein, “treatment” and “treating”, are used interchangeablyherein, and refer to an approach for obtaining beneficial or desiredresults including, but not limited to, therapeutic benefit. Bytherapeutic benefit is meant eradication or amelioration of theunderlying disorder being treated. Also, a therapeutic benefit isachieved with the eradication or amelioration of one or more of thephysiological symptoms associated with the underlying disorder such thatan improvement is observed in the patient, notwithstanding that thepatient can still be afflicted with the underlying disorder.

As used herein, “subject” or “patient” to which administration iscontemplated includes, but is not limited to, humans (i.e., a male orfemale of any age group, e.g., a pediatric subject (e.g., infant, child,adolescent) or adult subject.

As used herein, the term, “chelated copper” is defined to includesupplemental, man-made, and/or synthetically produced copper in the +1and/or +2 oxidation state where the charged copper includes theformation of at least one coordinate bond between the charged copper anda ligand, chelant, chelator, chelating agent, and/or sequestering agent.In some aspects, the chelated copper may include, for example, coppersulfate, copper acetate, copper carbonate, copper complexed with aminoacids (e.g., copper glycinate), copper complexed with polysaccharides,and/or copper proteinate.

As used herein, the term “naturally occurring copper” is defined toinclude naturally occurring forms of copper including copper in a zero(0) oxidation state having no ligand, chelant, chelator, chelatingagent, and/or sequestering agent; in addition, the naturally occurringcopper can include copper in the +1 and/or +2 oxidation state where thecharged copper includes at least one coordinate bond between the chargedcopper and a ligand, protein, chelant, chelator, chelating agent, and/orsequestering agent as naturally produced by plants or other organisms.In some aspects, the naturally occurring copper may comprise copperoxide including cupric oxide (CuO), cuprous oxide (Cu₂O), or acombination thereof. In some aspects, the naturally occurring copper maycomprise copper oxide and a blend of other metal oxides including zincoxide.

As used herein, the term “All Life Stage” and/or “Growth & Reproduction”pet food is currently defined to have a minimum of 12.4 ppm copper and ahigher crude protein content of at least 22.5 wt % as required by theAssociation of American Feed Control Officials (AAFCO). These minimumvalues of nutrient and ingredients defined herein for the “All LifeStage” and/or “Growth & Reproduction” pet food compositions may changebased on the Annual Official Publication release by AAFCO.

As used herein, the term “Adult Maintenance” pet food is currentlydefined to have a minimum of 7.3 ppm copper and a higher crude proteincontent of at least 18.0 wt % as required by the Association of AmericanFeed Control Officials (AAFCO). These minimum values of nutrient andingredients defined herein for the “Adult Maintenance” pet foodcomposition may change based on the Annual Official Publication releaseby AAFCO.

As used herein, the term “Sensitive Stomach, Skin, & Coat” is currentlydefined to have a minimum of 7.3 ppm copper as required by theAssociation of American Feed Control Officials (AAFCO). These minimumvalues of nutrient and ingredients defined herein for the “SensitiveStomach, Skin, & Coat” pet food composition may change based on theAnnual Official Publication release by AAFCO.

As used herein, unless otherwise indicated, the term “treat”, in all itsverb forms, is used herein to mean to relieve, alleviate, prevent,and/or manage at least one symptom of a disorder in a pet, the disorderincluding, for example, copper storage disease, dilated cardiomyopathy,adverse gastrointestinal food reactions, food allergies,gastrointestinal disorders, such as, irritable bowel syndrome,constipation-predominant irritable bowel syndrome, antibiotic responsivediarrhea, chronically soft stools (e.g., chronic cow pie stools),chronic flatulence, chronic stomach sounds, emesis with bile,borborygnus, dyspepsia, or any combinations of symptoms thereof. Withinthe meaning of the present invention, the term “treat” also denotes, toarrest, delay the onset (i.e., the period prior to clinicalmanifestation of a disease) and/or reduce the risk of developing orworsening a disease or ailment. The term “treatment” means the act of“treating” as defined above.

As used herein, the term “prevent” or “preventing” means to arrest,delay the onset (i.e., the period prior to clinical manifestation of adisease or ailment) or reoccurrence, and/or reduce the risk ofdeveloping copper storage disease, dilated cardiomyopathy, adversegastrointestinal food reactions, food allergies, and/or agastrointestinal disorder, such as, irritable bowel syndrome,constipation-predominant irritable bowel syndrome, antibiotic responsivediarrhea, chronically soft stools (e.g., chronic cow pie stools),chronic flatulence, chronic stomach sounds, emesis with bile,borborygnus, dyspepsia, or any combinations of symptoms thereof relativeto a pet that has not been treated or fed the pet food compositionsdescribed herein.

As used herein, the term “pet” means a domestic or tamed animal kept forcompanionship or pleasure. Examples of a pet include, but are notlimited to, dogs, cats, birds, ferrets, gerbils, rabbits, chickens,lizards, goats, hamsters, hedgehogs, ponies, horses, parrots, pigeons,sheep, sugar gliders, turtles, turkeys, potbellied pigs, and anycombinations thereof.

As used herein, the term “and/or,” when used in a list of two or moreitems, means that any one of the listed items can be employed by itself,or any combination of two or more of the listed items can be employed.For example, if a composition is described as containing components A,B, and/or C, the composition can contain A alone; B alone; C alone; Aand B in combination; A and C in combination; B and C in combination; orA, B, and C in combination.

Copper Storage Disease

There has been an increased prevalence of copper associated liver injuryin dogs over the last 15-20 years. The change in requirements by theAssociation of American Feed Control Officials (“AAFCO”) to includecopper sulfate and/or copper proteinate as a copper fortifier in theirfood products has been determine to lead to the gradual increase ofcopper accumulation in many dogs to the point that the risk ofdeveloping Copper Storage Disease (“CSD”) which results in hepatitis andproceeds eventually to cirrhosis and ultimately death of the dog unlessdiagnosed and treated in a timely fashion. Despite no evidence of copperdeficiency in dogs (experimental or clinical), this AAFCO recommendationwas made to exchange unavailable copper moieties (e.g., copper oxides,others) used in canine diet formulations with bioavailable coppersulfate or chelates typically delivered using premixes. Recent researchand Table 1 below indicate that the amount of copper detected inbiopsied livers by veterinarians have increased at an alarming rate.

TABLE 1 Hepatic Copper Concentrations in Dogs Over Time Year Hepatic Cuμg/g dry weight References 1929 6.8 Flinn F B, Inouye J M, 1929 1932 44Meyer A E, Eggreet C, 1932 1956 80 Beck, 1956 1972 154 Gumbell, 19721981-1997 117-250 Su L C, et al., 1982 Keen C L, et al., 1981 Zenter J.Meyer H., 1991 2002-2015 262-753 Schultheiss P C, et al., 2002 Cedeno,et al., 2016 Johnson A J, et al., 2013 Strickland J M, et al., 2018This increased copper accumulation coincides with the date that AFFCOrequired copper sulfate and/or copper proteinate to be used as compoundsfor copper fortification in pet food formulations. In some instances,dogs that develop mild cases of CSD, e.g., 1,000 ppm to 1,800 ppm copperin a liver sample, may show no outward signs or symptoms of the CSDdisease. Elevated amounts of copper in the liver, e.g., the 1,000 ppm to1,800 ppm amounts noted, may become problematic when the pet/animal isprescribed a non-steroidal anti-inflammatory drug (NSAIDs) or otherxenobiotic which can lead to the pet into having a liver crisis, whichcan frequently end in death. Such liver crises are becoming morefrequent as more NSAIDS and other drugs are metabolized by the liver.The presence of a healthy liver containing less than 500 ppm copper isat least one important factor in considering the safety of using theseproducts/compositions in dogs and other pets.

As of 2018, most AAFCO approved diets in the U.S. for canines containcopper sulfate and/or copper proteinate fortification. A large portionof the dog population in the U.S. is currently at some risk ofdeveloping CSD because of copper sulfate (CS) and/or copper proteinate(CP) being added to most dog foods. While rate of gain is a useful meansof measurement in livestock, this parameter is typically not applicableto pets or their pet food formulations. CSD is grossly under diagnosedby veterinarians and their clients as they are reluctant to surgicallybiopsy healthy or unhealthy patients since this is the only way todiagnose CSD. Thus, the appropriate treatment of D-penacillamine isseldom prescribed. Experts believe that 90-95% of CSD goes undiagnosedand the dog dies from chronic liver failure of unknown origin. The mostimmediate course of action is to limit copper fortification andeliminate CS and CP from the dog food diets. Simply stated, in someaspects, eliminating highly bioavailable copper (e.g., copper sulfateand copper proteinate) one can eliminate the ingredient that causes thecopper to build up in the liver and contributes to CSD.

Professor Sharon Center published an article on Canine Chronic Hepatitisin the Merck Manual of Veterinary Medicine that can be found atwww.merckvetmanual.com, which is incorporated herein by reference in itsentirety, an excerpt of which is provided here. Chronic hepatitis thatdoes not focus on biliary structures is more common in dogs than cats.Several breeds are predisposed, including Bedlington Terriers, LabradorRetrievers, Cocker Spaniels, Doberman Pinschers, Skye Terriers, StandardPoodles, West Highland White Terriers, Springer Spaniels, Chihuahuas,and Maltese. Although there is an identifiable etiology for somecategories of chronic hepatitis, in most cases the cause remainsunidentified. Increased hepatocellular copper and Kupffer cell ironstores are common in dogs with chronic hepatitis. The degree of metalaccumulation and its acinar location help determine its relevance totissue injury. Other associated conditions include infectious caninehepatitis, chronic hepatitis secondary to infectious processes, andchronic exposure to xenobiotics (including certain drugs, biologictoxins, and chemicals). Terminology that reflects specific etiology orbreed predilection, such as drug-associated chronic hepatitis,infectious chronic hepatitis, copper-associated hepatitis, etc., ispreferred. The term idiopathic chronic hepatitis indicates that anetiology has not been determined. Histopathologic changes are generallysimilar in all cases of chronic hepatitis, regardless of the underlyingcause, and include a lymphocytic-plasmacytic inflammation withinfiltrates extending into hepatic parenchyma, variable single cell orpiecemeal necrosis, and in advanced disease, development of bridgingfibrosis and nodular regeneration. The acinar zone of involvement varieswith the underlying cause.

Copper-associated hepatopathy is a leading cause of chronic hepatitis indogs, increasing in prevalence since 1997 when copper supplements incommercial dog foods were modified to a more bioavailable form.Retrospective evaluation of liver biopsies from Labrador Retrievers andDoberman Pinschers from 1982 to 2015 indicated that dogs of thesebreeds, with and without chronic hepatitis, had significantly higherhepatic copper concentrations in the last 10 years of the study.Management of body copper homeostasis relies on numerous coppertransporters, chaperones, and binding proteins, as well as biliarycanalicular egress. Copper-associated hepatopathy is best characterizedin Bedlington Terriers, which have a mutation (deletion of exon 2) ofthe COMMD1 copper transporter protein. Careful breeding programs guidedby liver biopsy and genetic testing (PCR gene mutation test) haveremarkably reduced disease frequency in Bedlington Terriers. However,some Bedlington Terriers with biopsy-confirmed copper-associatedhepatopathy lack this specific gene mutation.

Food Compositions and Methods of Making

According to some embodiments disclosed herein, a pet food compositionis provided. The pet food composition comprises: a naturally occurringcopper concentration from about 7.3 ppm to about 25.0 ppm; an omega-6fatty acid and an omega-3 fatty acid wherein the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 10:1; at least onemineral including a zinc oxide concentration from about 150 mg/kg toabout 1000 mg/kg; and two or more vitamins including: a vitamin Econcentration from about 300 iu/kg to about 1000 iu/kg; and a vitamin B6concentration from about 2 mg/kg to about 50 mg/kg. All of thequantities provided, including for example, weight amounts, percentages,ppm, are provided with respect to a dry matter basis. The followingembodiment is provided with this additional “on a dry matter basis”descriptor to exemplify its ability to be read into each quantity listedherein. The descriptor “on a dry matter basis” is omitted elsewhere inother embodiments for brevity only.

According to other embodiments of this invention, the pet foodcomposition comprises: a naturally occurring copper concentration fromabout 7.3 ppm to about 15.0 ppm on a dry matter basis; an omega-6 fattyacid and an omega-3 fatty acid wherein the omega-6 fatty acid to omega-3fatty acid ratio is from about 5:1 to about 10:1 on a dry matter basis;at least one mineral including a zinc oxide concentration from about 150mg/kg to about 500 mg/kg on a dry matter basis; and two or more vitaminsincluding: a vitamin E concentration from about 300 iu/kg to about 500iu/kg on a dry matter basis; and a vitamin B6 concentration from about1.5 mg/kg to about 25 mg/kg on a dry matter basis.

In some aspects, the pet food composition is selected from the groupconsisting of a dog food, a cat food, a dog treat, a cat treat, andcombinations thereof. In some aspects, the pet food composition is a dogfood. In other aspects, the pet food composition is a dog treat. In someaspects, the pet food is provided having no or substantially no chelatedcopper, copper sulfate, and/or copper proteinate, but still meets theminimum standards set by AAFCO, for example but not limited to 7.3 ppmof copper. The pet food compositions or diets disclosed hereinincorporate one or more ingredients having a naturally occurring coppersource to provide a naturally occurring copper concentration of at least7.3 ppm since these one or more ingredients have naturally occurringand/or non-chelated copper naturally disposed in them. In some aspects,the copper concentration in the pet food composition is introduced usingan ingredient comprising for example, but is not limited to, tomatopumice, flaxseed, linseed, pumpkin, carrot, field peas, chickpeas,potatoes, beets, dry yeast, yeast, or any combinations thereof withoutusing any copper fortification. In some aspects, all of the copperintroduced to the pet food composition comes from the naturallyoccurring copper found in plants, yeasts, and/or other natural, non-manmade materials. In some aspects, all of the copper introduced to the petfood composition comes from naturally occurring copper and copperoxides. In some aspects, all of the copper introduced to the pet foodcomposition is a naturally occurring and non-bioavailable coppercompound. In some aspects, all of the copper introduced to the pet foodcomposition is a naturally occurring and limited-bioavailable coppercompound.

Copper is an essential trace mineral, which means a pet only needs verysmall amounts of it for normal function. Elemental copper is notwell-absorbed and high doses via supplements typically lead to stomachupset and other symptoms. Chelated copper is a special type of mineralsupplement that may be better absorbed and easier on the stomach,although scientific evidence is lacking. Regardless, there is a dangerof toxicity and serious health consequences if a pet consumes too muchchelated copper. Chelated mineral supplements can frequently includeminerals combined with amino acids. In some aspects, some common formsof chelated copper includes copper sulfate, copper proteinate, and/orcopper glycinate, which is a molecular complex that consists ofelemental copper and a chelating molecule. Manufacturers of chelatedmineral supplements can frequently claim these supplements are morebioavailable because organic molecules can sometimes pass easily throughthe intestinal tract.

The amount of copper provided or added to the pet food composition maybe adjusted according to a variety of different factors including, forexample, breed, size, gender, activity level, and/or medical history.The minimum level of copper added to a pet food composition may becontrolled by the requirements provided by AAFCO and may fluctuate basedon future studies related to CSD and other copper or micronutrientlevels. In some aspects, the copper concentration may range from about2.5 ppm to about 100 ppm, from about 2.5 ppm to about 75.0 ppm, fromabout 2.5 ppm to about 50.0 ppm, from about 2.5 ppm to about 25.0 ppm,from about 2.5 ppm to about 15.0 ppm, from about 2.5 ppm to about 13.5ppm, from about 2.5 ppm to about 12.0 ppm, from about 2.5 ppm to about10.0 ppm, from about 2.5 ppm to about 7.3 ppm, from about 5.0 ppm toabout 100 ppm, from about 5.0 ppm to about 75.0 ppm, from about 5.0 ppmto about 50.0 ppm, from about 5.0 ppm to about 25.0 ppm, from about 5.0ppm to about 15.0 ppm, from about 5.0 ppm to about 13.5 ppm, from about5.0 ppm to about 12.0 ppm, from about 5.0 ppm to about 10.0 ppm, fromabout 5.0 ppm to about 7.3 ppm, from about 7.3 ppm to about 100 ppm,from about 7.3 ppm to about 75.0 ppm, from about 7.3 ppm to about 50.0ppm, from about 7.3 ppm to about 25.0 ppm, from about 7.3 ppm to about15.0 ppm, from about 7.3 ppm to about 13.5 ppm, from about 7.3 ppm toabout 12.0 ppm, from about 7.3 ppm to about 10.0 ppm, from about 7.3 ppmto about 9.0 ppm, or from about 7.3 ppm to about 8.0 ppm. In someaspects, the copper concentration may be about 1 ppm, about 2 ppm, about3 ppm, about 4 ppm, about 5 ppm, about 6 ppm, about 7 ppm, about 7.3ppm, about 8.0 ppm, about 9 ppm, about 10 ppm, about 11 ppm, about 12ppm, about 13 ppm, about 13.3 ppm, about 14 ppm, about 15 ppm, about 20ppm, about 25 ppm, about 50 ppm, about 75 ppm, or about 100 ppm.

The amount of fatty acids provided or added to the pet food compositionmay be adjusted according to a variety of different factors including,for example, breed, size, gender, activity level, and/or medicalhistory. The minimum level of fatty acids added may be controlled by therequirements provided by AAFCO and may fluctuate based on futurestudies. The omega-6 fatty acid to omega-3 fatty acid ratio may be addedto the pet food composition in an amount from about 1:1 to about 10:1,from about 1:1 to about 5:1, or from about 5:1 to about 10:1, where theomega-6 and omega-3 fatty acids are added to help prevent an arachidonicacid cascade. The corresponding pet food composition having omega-6and/or omega-3 fatty acids may help prevent the arachidonic acid cascadethat can occur in a case of hepatitis (inflammation of the liver). Insome aspects, the omega-6 fatty acid to omega-3 fatty acid ratio is fromabout 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1,13:1, 14:1, or about 15:1. In some aspects, the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 5:1 where theomega-6 and omega-3 fatty acids are added to help prevent an arachidonicacid cascade.

The amount of minerals, either individually or in combination, providedor added to the pet food composition may be adjusted according to avariety of different factors including, for example, breed, size,gender, activity level, and/or medical history. The minimum level ofzinc oxide, an exemplary mineral, added may be controlled by therequirements provided by AAFCO and may fluctuate based on futurestudies. The zinc oxide concentration may added to the food compositionin an amount from about 150 mg/kg to about 1000 mg/kg, from about 150mg/kg to about 500 mg/kg, from about 150 mg/kg to about 250 mg/kg, orfrom about 250 mg/kg to about 500 mg/kg where the zinc oxideconcentration is added to help prevent or slow down copper absorption bythe gastrointestinal tract of the pet/animal. In some aspects, the zincoxide concentration may be about 50 mg/kg, about 100 mg/kg, about 150mg/kg, about 200 mg/kg, about 250 mg/kg, about 300 mg/kg, about 350mg/kg, about 400 mg/kg, about 450 mg/kg, about 500 mg/kg, about 550mg/kg, about 600 mg/kg, about 650 mg/kg, about 700 mg/kg, about 750mg/kg, about 800 mg/kg, about 850 mg/kg, about 900 mg/kg, about 950mg/kg, or about 1,000 mg/kg.

The amount of vitamins provided or added to the pet food composition maybe adjusted according to a variety of different factors including, forexample, breed, size, gender, activity level, and/or medical history.The minimum level of vitamins added may be controlled by therequirements provided by AAFCO and may fluctuate based on futurestudies. The vitamin E concentration added to the pet food compositionmay be from about 300 iu/kg to about 1000 iu/kg, from about 300 iu/kg toabout 700 iu/kg, or from about 300 iu/kg to about 500 iu/kg, where thevitamin E concentration is added to provide an antioxidant. In someaspects, the vitamin E concentration is added as an antioxidant to helpprevent an arachidonic acid cascade. In other aspects, the vitamin Econcentration, omega-6 fatty acid concentration, and omega-3 fatty acidconcentration can work together to help prevent an arachidonic acidcascade.

In some aspects, the vitamins may include at least one water-solublevitamin. The at least one water-soluble vitamin may include a vitamin B6concentration added to the pet food composition in an amount from about1.5 mg/kg to about 50 mg/kg, from about 1.5 mg/kg to about 50 mg/kg,from about 2 mg/kg to about 50 mg/kg, from about 2 mg/kg to about 25mg/kg, or from about 10 mg/kg to about 25 mg/kg where the vitamin B6concentration is added to help prevent cirrhosis in hepatic necrosis. Insome aspects, the at least one water-soluble vitamin may include avitamin B6 concentration added to the pet food composition in an amountof about 1.5 mg/kg, about 2 mg/kg, about 5 mg/kg, about 10 mg/kg, about15 mg/kg, about 20 mg/kg, about 25 mg/kg, about 30 mg/kg, about 35mg/kg, about 40 mg/kg, about 45 mg/kg, or about 50 mg/kg.

In some aspects, the pet food composition may include a combination ofDL-methionine and taurine to prevent, treat, reduces the effects of,and/or reduce the chances of dilated cardiomyopathy in pets. In someaspects, the DL-methionine may be added to the pet food in an amountfrom about 5 mg/kg to about 2,000 mg/kg, from about 5 mg/kg to about1,500 mg/kg, from about 5 mg/kg to about 1,000 mg/kg, from about 5 mg/kgto about 750 mg/kg, from about 5 mg/kg to about 500 mg/kg, or from about5 mg/kg to about 250 mg/kg. In some aspects, the amount of DL-methioninein the pet food composition may be about 100 mg/kg, about 200 mg/kg,about 300 mg/kg, about 400 mg/kg, about 500 mg/kg, about 600 mg/kg,about 700 mg/kg, about 800 mg/kg, about 900 mg/kg, about 1,000 mg/kg,about 1,250 mg/kg, about 1,500 mg/kg, about 1, 750 mg/kg, or about 2,000mg/kg. In some aspects, the taurine may be added to the pet food in anamount from about 5 mg/kg to about 20 g/kg, from about 5 mg/kg to about15 g/kg, from about 5 mg/kg to about 10 g/kg, or from about 5 mg/kg toabout 5 mg/kg. In some aspects, the amount of taurine in the pet foodcomposition may be about 1 g/kg, about 2 g/kg, about 3 g/kg, about 4g/kg, about 5 g/kg, about 6 g/kg, about 7 g/kg, about 8 g/kg, about 9g/kg, about 10 g/kg, about 15 g/kg, about 17 g/kg, or about 20 g/kg. Insome aspects, the ratio of taurine to DL-methionine is from about 1:1,2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1, 13:1, 14:1, orabout 15:1. In some aspects, the ratio of taurine to DL-methionine isabout 10:1 and the combination of DL-methionine and taurine prevents,treats, reduces the effects of, and/or reduce the chances of dilatedcardiomyopathy in pets.

In some aspects, the pet food composition may include no, orsubstantially no, chelated copper, supplemental copper, non-naturallyoccurring copper, sulfate ions, copper sulfate, copper acetate, coppercarbonate, copper complexed with amino acids (e.g., copper glycinate),copper complexed with polysaccharides, copper proteinate, beef, milk,wheat, and any combinations thereof. In some aspects, the pet foodcomposition may include no added copper sulfate. In some aspects, thepet food composition may include no added chelated copper. In otheraspects, the pet food composition may include no beef, milk, and wheatto prevent, treat, reduce the effects of, and/or reduce the chances offood allergies in pets. In still other aspects, the pet food compositionmay include no added chelated minerals, for example, but not limited to,metal sulfates, metal carbonates, metal acetates, metal glycinates,metal citrates, and metal amino acids.

In some aspects, the pet food composition may be a prophylactic diet andnot a therapeutic diet. In other aspects, the pet food composition maybe both a prophylactic diet and a therapeutic diet. In still otheraspects, the pet food composition may be a therapeutic diet and not aprophylactic diet. The term “prophylactic diet” as used herein isdefined to include those pet food diets that do not require aprescription from a veterinarian or other pet/animal care provided to beadministered. The term “therapeutic diet” as used herein is defined toinclude those pet food diets that require a prescription from aveterinarian or other pet/animal care provided to be administered. Insome aspects, the prophylactic diet may be used as maintenance diet thatis administered to the pet over a prolonged and extended period of timefor the pet. In some aspects, the prophylactic diet using the pet foodcomposition may be administered to the pet over a period including fromabout 1 month to about 20 years, from about 1 month to about 15 years,from about 1 month to about 10 years, from about 1 month to about 5years, from about 1 week to over 1 year, or from about 1 week to about 6months. In some aspects, the prophylactic diet using the pet foodcomposition may be administered to the pet over the lifetime of the pet.In other aspects, the prophylactic diet using the pet food compositionmay be administered to the pet using variations of the pet foodcomposition including: an “All Life Stage” pet food composition; an“Adult Maintenance” pet food composition; a “Growth & Reproduction” petfood composition; and a “Sensitive Stomach, Skin, & Coat” pet foodcomposition.

In some embodiments, a method of forming a pet food composition isprovided. The method includes: providing a formula or meal base (mealbase used in dry food compositions) selected from the group consistingof chicken, corn gluten, fish, duck, anchovy, sardine, venison, ostrich,rabbit, pea, potato, barley, rice, corn, and any combinations thereof;adding one or more ingredients having a naturally occurring coppersource to provide a naturally occurring copper concentration in the petfood composition from about 7.3 ppm to about 25.0 ppm; adding an omega-6fatty acid and an omega-3 fatty acid wherein the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 10:1; adding atleast one mineral including a zinc oxide concentration from about 150mg/kg to about 1000 mg/kg; and adding two or more vitamins including avitamin E concentration from about 300 iu/kg to about 1000 iu/kg and avitamin B6 concentration from about 2 mg/kg to about 50 mg/kg.

It is understood that the descriptions outlining and teaching the petfood composition previously discussed, which can be used in anycombination, apply equally well to the method of forming the pet foodcomposition.

In some embodiments, a method of forming an AAFCO compliant or a AAFCOcertified pet food composition containing substantially no coppersulfate and/or copper proteinate, the method including: providing aformula or meal base (meal base used in dry food compositions)comprising chicken, corn gluten, fish, duck, anchovy, sardine, venison,ostrich, rabbit, pea, potato, barley, rice, corn, and any combinationsthereof; adding one or more ingredients having a naturally occurringcopper source to provide a naturally occurring copper concentration inthe pet food composition from about 7.3 ppm to about 25.0 ppm; adding anomega-6 fatty acid and an omega-3 fatty acid wherein the omega-6 fattyacid to omega-3 fatty acid ratio is from about 1:1 to about 10:1; addingat least one mineral including a zinc oxide concentration from about 150mg/kg to about 1000 mg/kg; and adding two or more vitamins including avitamin E concentration from about 300 iu/kg to about 1000 iu/kg and avitamin B6 concentration from about 2 mg/kg to about 50 mg/kg to formthe AAFCO compliant or AAFCO certified pet food composition.

It is understood that the descriptions outlining and teaching the petfood composition previously discussed, which can be used in anycombination, apply equally well to the method of forming the AAFCOcompliant or AAFCO certified pet food composition containingsubstantially no copper sulfate and/or copper proteinate and no addedchelated copper (e.g., copper sulfate and copper proteinate).

Treating and/or Preventing Disease and Ailments in Pets

In some aspects, a method of reducing copper accumulation in pets isprovided. The method includes: providing a chicken, corn gluten, duck,anchovy, sardine, fish, venison, ostrich, rabbit, pea, potato, barley,rice, corn, and any combinations thereof, formula or meal base; andadding one or more ingredients having a naturally occurring coppersource to provide a naturally occurring copper concentration in the petfood composition from about 7.3 ppm to about 15.0 ppm, from about 7.3ppm to about 12.0 ppm, or from about 7.3 ppm to about 10.0 ppm whereinthe copper concentration is not a chelated copper source.

It is understood that the descriptions outlining and teaching the petfood composition previously discussed, which can be used in anycombination, apply equally well to the method of reducing copperaccumulation in pets.

In additional aspects, the method may further include adding an omega-6fatty acid and an omega-3 fatty acid wherein the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 10:1, from about 1:1to about 5:1, or from about 5:1 to about 10:1 where the omega-6 andomega-3 fatty acids are added to help prevent an arachidonic acidcascade. The corresponding pet food composition having omega-6 and/oromega-3 fatty acids may help prevent the arachidonic acid cascade thatcan occur in a case of hepatitis (inflammation of the liver). In someaspects, the omega-6 fatty acid to omega-3 fatty acid ratio is fromabout 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1,13:1, 14:1, or about 15:1. In some aspects, the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 5:1 where theomega-6 and omega-3 fatty acids are added to help prevent an arachidonicacid cascade.

In other aspects, the method may further include adding at least onemineral including a zinc oxide concentration from about 150 mg/kg toabout 1000 mg/kg, from about 150 mg/kg to about 500 mg/kg, from about150 mg/kg to about 250 mg/kg, or from about 250 mg/kg to about 500 mg/kgwhere the zinc oxide concentration is added to help prevent copperabsorption by a gastrointestinal tract.

In still other aspects, the method may still further include adding atleast one vitamin including a vitamin E concentration from about 300iu/kg to about 1000 iu/kg, from about 300 iu/kg to about 700 iu/kg, orfrom about 300 iu/kg to about 500 iu/kg, where the vitamin Econcentration is added to provide an antioxidant. In some aspects, thevitamin E concentration is added as an antioxidant to help prevent anarachidonic acid cascade. In other aspects, the vitamin E concentration,omega-6 fatty acid concentration, and omega-3 fatty acid concentrationcan work together to help prevent an arachidonic acid cascade.

In further aspects, the method may still yet include adding at least onewater-soluble vitamin including a vitamin B6 concentration from about 2mg/kg to about 50 mg/kg, from about 2 mg/kg to about 25 mg/kg, or fromabout 10 mg/kg to about 25 mg/kg where the vitamin B6 concentration isadded to help prevent cirrhosis in hepatic necrosis.

In some aspects, the pet food composition eliminates the use of beef,pork and/or sheep by-products to prevent adding ingredients that maycontain livers that are storing copper sulfate and/or copper proteinate.Since beef, pork and/or sheep, for example, are species that are fedcommercial livestock diets including copper sulfate and/or copperproteinate, eliminated these types derivative by-products can helpminimize or eliminate the introduction of sulfate ions that maysubsequently chelate copper. It is hypothesized that cattle, pigs andsheep raised for meat have reasonably short lives and rarely arenegatively affected by CSD. Because of this lack of concern, these typesof livestock species can be fed generous amounts of copper sulfateand/or copper proteinate to increase rate of gain and reduce time toslaughter.

In some aspects, the liver function of a pet may be improved ormaintained using the pet food composition. For example, in some aspects,the pet food composition may improve a pet's liver function from about10% to about 50%, from about 10% to about 60%, from about 10% to about70%, from about 10% to about 75%, from about 10% to about 80%, fromabout 10% to about 90%, from about 10% to about 95%, from about 10% toabout 100%, from about 25% to about 50%, from about 25% to about 60%,from about 25% to about 70%, from about 25% to about 75%, from about 25%to about 80%, from about 25% to about 90%, from about 25% to about 95%,from about 25% to about 100%, from about 50% to about 60%, from about50% to about 70%, from about 50% to about 75%, from about 50% to about80%, from about 50% to about 90%, from about 50% to about 95%, fromabout 50% to about 100%, from about 75% to about 80%, from about 75% toabout 90%, from about 75% to about 95%, or from about 75% to about 100%where the liver function may be measured by taking a biopsy of the petor by performing a bile-acid detection.

In some aspects, the method of treating pets using the pet foodcomposition may include a prophylactic diet and not a therapeutic diet.In other aspects, the method of treating pets using the pet foodcomposition may include both a prophylactic diet and a therapeutic diet.In still other aspects, the method of treating pets using the pet foodcomposition may include a therapeutic diet and not a prophylactic diet.

In some embodiments, a method of preventing copper storage disease in apet is provided. The method comprises: making a prophylactic pet foodcomposition including: a formula or meal base comprising chicken,chicken meal, corn gluten, fish, duck, anchovy, sardine, venison,ostrich, rabbit, pea, potato, barley, rice, corn, and any combinationsthereof; a naturally occurring copper concentration from about 7.3 ppmto about 25.0 ppm; at least one mineral including a zinc oxideconcentration from about 150 mg/kg to about 1000 mg/kg; and two or morevitamins including a vitamin E concentration from about 300 iu/kg toabout 1000 iu/kg and a vitamin B6 concentration from about 2 mg/kg toabout 50 mg/kg. The method further comprises feeding the pet theprophylactic pet food composition to prevent copper storage disease. Insome aspects, the method further comprises preventing dilatedcardiomyopathy in a pet where the prophylactic pet food compositionfurther comprises DL-methionine and taurine. In some aspects, the methodfurther comprises preventing adverse gastrointestinal food reactionswhere the prophylactic pet food composition further comprises an omega-6fatty acid and an omega-3 fatty acid wherein the omega-6 fatty acid toomega-3 fatty acid ratio is from about 1:1 to about 5:1. In someaspects, the method further comprises preventing food allergies wherethe prophylactic pet food composition further comprises substantially nobeef, substantially no milk, and substantially no wheat. In someaspects, the prophylactic pet food composition is an AAFCO compliant orAAFCO certified pet food composition.

It is understood that the descriptions outlining and teaching the petfood composition and methods previously discussed, which can be used inany combination, apply equally well to the method of preventing copperstorage disease, preventing dilated cardiomyopathy, preventing adversegastrointestinal food reactions, and/or preventing food allergies inpets. In some aspects, the pet food composition prevents or reducescopper storage disease, dilated cardiomyopathy, adverse gastrointestinalfood reactions, and preventing food allergies in pets.

EXAMPLES Example 1—The Healthy Liver Package Bundle

No copper fortification or chelated copper is added to the pet foodcomposition. Omega-6 and omega-3 fatty acids are present in anomega-6:omega-3 ratio of 5:1 to 10:1. Zinc Oxide is added to thecomposition in no less than 150 mg/kg-500 mg/kg amount, the vitamin B6is present in no less than an 2.0 mg/kg-25 mg/kg max amount, the vitaminE is added in no less than a 300 iu/kg-500 iu/kg max amount. The petfood composition contains all or substantially all of its vitamin orminerals in a non-sulfate or non-chelated form. Limiting or completelyeliminating any and all beef, swine and sheep by-products canadditionally and drastically reduce the copper sulfate and/or copperproteinate introduced into this diet.

Example 2

An “All life stage” product is based on AAFCO nutrient recommendationsto provide a diet that is nutritionally adequate for any age or phase oflife of a dog. Chicken meal and corn gluten meal may be the first twoingredients used in the preparation of this example pet foodcomposition. Barley, corn, and rice can all be added in equal amountsfor maximum labeling flexibility. As compared to the Diamond CareSensitive Skin Formula competitor formulation, this example contains:23% total protein versus 22% in the Diamond formulation; 15% fat versus12% fat in the Diamond formulation; a omega-6 to omega-3 fatty acidratio of 5:1 versus a 3:1 ratio in the Diamond formulation due to feweromega-3 fatty acids used (0.47% vs. 0.8%) and similar omega-6 fattyacids (2.4% vs. 2.5%); 175 ppm zinc versus 150 ppm zinc in the Diamondformulation; and 0.65 ppm selenium versus 0.35 ppm selenium in theDiamond formulation. In addition, this pet food composition includes:vitamin B-6 (pyridoxine) at a 2.25 ppm amount to ensure the diet hitsthe 2.0 ppm target; biotin at a 1.0 ppm amount; and copper at a 9.1 ppmamount to meet the AAFCO recommendation of 8.0 ppm. On a dry matterbasis, 1 mg/kg is defined to be equivalent to 1 ppm. A quantitativeanalysis of the naturally occurring copper present in the ingredientsand this pet food composition determined the amount of copper eachingredient contributed to the total copper amount as provided in Table 2below.

TABLE 2 Copper Contribution by Ingredient (estimate of % of totalcopper) Ingredient % of Total Copper Corn gluten meal 38.6% Rice 15.2%Chicken meal 15.1% Barley 12.2% Corn 6.1% Beet pulp 5.4% Dried yeast3.9% Potato flakes 2.9% Vitamins and Minerals 0.6%

Example 3

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 3 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 3 Ingredients Weight Percent of Total Composition Chicken Meal14.60% Corn Gluten Meal 14.55% Barley 14.50% Corn 14.50% Rice 14.50%Poultry Fat 10.45% Dried Yeast 6.10% Beet Pulp 3.79% MonocalciumPhosphate 1.72% Calcium Carbonate 1.51% Flaxseed 1.04% Salt 0.75%Natural Flavors 0.50% Vitamins and Minerals 0.50% Potassium Chloride0.41% Preservatives 0.30% Choline chloride 0.27%

The pet food composition made from the ingredients provided in Table 3did not feed as well using the a dry mix of natural flavors as it didusing the liquid natural flavors used in other examples.

As provided in Table 4 below, the amount of copper meets the AAFCOrequirements and falls within the other desired nutrient, mineral, andcomponent ranges provided herein.

TABLE 4 Ingredient Amount in Food Composition Copper  7.30 mg/kg Zinc184.93 mg/kg Omega-6 Fatty Acid  4.72% Omega-3 Fatty Acid  0.472%Taurine 540.20 mg/kg DL-methionine 0.6466% Vitamin E   300 iu/kg VitaminB6 2.2500 mg/kg

Example 4

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 5 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 5 Ingredients Weight Percent of Total Composition SalmonHydrolysate 14.50% Pea Flour 13.75% Peas 13.75% Chick pea powder 13.38%Potato Flaked 12.14% Poultry Fat 8.73% Dried Yeast 8.00% Tomato Pomace5.00% Monocalcium Phosphate 2.61% Calcium carbonate 2.43% Beet Pulp2.00% Flaxseed 1.25% Salt 0.70% Natural Flavors 0.50% Vitamins andMinerals 0.50% Natural Preservatives 0.30% Choline chloride 0.27%Taurine 0.20%

While the salmon can be an important first ingredient to use in thisSkin & Coat pet food composition, the source of the salmon or otherprotein source is important in terms of providing the desired amount ofcopper. As provided in Table 6 below, the relatively high amount ofcopper present in this example pet food composition is a result of usingfarm-raised salmon that are typically fed copper sulfate or otherchelated copper products to help the fish gain mass to be used as a foodsource. Similar to cattle, sheep, fish, pigs, poultry, and otherlivestock, the consumption of chelated copper sources to gain mass canbe subsequently passed through to dogs and other pets through theseanimals used to make pet food compositions. Example 4 demonstrates thedirect consequence on pet food copper concentrations where the amount ofcopper in the pet food can depend on the animal's history that is usedto make the food.

As provided in Table 6 below, the amount of copper, although elevated,meets the AAFCO requirements and falls within the other desirednutrient, mineral, and component ranges provided herein.

TABLE 6 Ingredient Amount in Food Composition Copper  24.0122 mg/kg Zinc280.7814 mg/kg Omega-6 Fatty Acid 1.6884% Omega-3 Fatty Acid 0.3377%Taurine  1,990.00 mg/kg DL-methionine 0.4633% Vitamin E    300 iu/kgVitamin B6  2.2500 mg/kg

Example 5

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 7 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 7 Ingredients Weight Percent of Total Composition SalmonHydrolysate 15.39% Pea Flour 15.00% Peas 15.00% Potato Flaked 15.00%Poultry Fat 7.70% Pea Protein 5.00% Chick pea powder 5.00% Beet Pulp5.00% Pumpkin Powder 3.00% Carrot Powder 3.00% Tomato Pomace 3.00%Monocalcium Phosphate 2.79% Calcium Carbonate 2.64% NaturalPreservatives 1.00% Salmon Digest 1.00% Salmon Oil 0.72% Salt 0.50%Vitamins and Minerals 0.50% Natural Preservatives 0.30% Choline Chloride0.27% Taurine 0.20%

The use of wild caught salmon in this Example 5 provided a low amount ofcopper in the pet food composition as compared to the elevated copperintroduced by the farm raised salmon in Example 4. The 5.58 mg/kg levelof copper in this example does not meet the AAFCO requirements and thusthis example 5 fails as a usable food composition. The copper level inthis formulation could be increased using dry yeast, yeast, tomatopumice, flaxseed, linseed, pumpkin, carrot, field peas, chickpeas,potatoes, beets, or any combinations thereof to up the amount ofnaturally occurring copper present in the pet food composition.

As provided in Table 8 below, the amount of copper does not meet theAAFCO requirements and falls within the other desired nutrient, mineral,and component ranges provided herein.

TABLE 8 Ingredient Amount in Food Composition Copper 5.5810 mg/kg Zinc177.0714 mg/kg  Omega-6 Fatty Acid 1.3683% Omega-3 Fatty Acid 0.2737%Taurine 1,990.00 mg/kg   DL-methionine 0.3425% Vitamin E   300 iu/kgVitamin B6 2.2500 mg/kg

Example 6

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 9 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 9 Ingredients Weight Percent of Total Composition SalmonHydrolysate 19.79% Peas 18.00% Potatoes 18.00% Pea flour 10.00% Poultryfat 7.05% Chick pea powder 5.00% Monocalcium phosphate 3.27% Beet pulp3.00% Pumpkin powder 3.00% Carrot powder 3.00% Tomato pomace 3.00%Calcium carbonate 2.44% Natural Flavors 1.00% Salmon digest flavor 1.00%Salmon oil 0.64% Salt 0.50% Vitamins and Minerals 0.50% NaturalPreservatives 0.30% Choline chloride 0.27% Taurine 0.25%

The use of wild caught salmon in Example 6 and its corresponding lowamount of copper, as demonstrated in Example 5, can be supplementedthrough the addition of ingredients containing naturally occurringcopper including pumpkin, carrot, peas, and beets to the pet foodcomposition to meet the AAFCO requirements.

As provided in Table 10 below, the amount of copper meets the AAFCOrequirements and falls within the other desired nutrient, mineral, andcomponent ranges provided herein.

TABLE 10 Ingredient Amount in Food Composition Copper 7.3000 mg/kg Zinc  190 mg/kg Omega-6 Fatty Acid  3.900% Omega-3 Fatty Acid 0.7800%Taurine  2,400 mg/kg DL-methionine  0.83% Vitamin E   300 iu/kg VitaminB6 2.2500 mg/kg

Example 7

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 11 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 11 Ingredients Weight Percent of Total Composition Pollock meal16.10% Barley 15.00% Rice 15.00% Chicken meal 10.77% Poultry Fat 9.99%Oats 7.80% Flaxseed 5.00% Dry Yeast 4.23% Beet Pulp 3.00% Pumpkin Powder3.00% Carrot Powder 3.00% Tomato Pomace 3.00% Natural flavors 2.00% Salt0.75% Vitamins and Minerals 0.50% Natural Preservatives 0.30% Cholinechloride 0.24% Taurine 0.20% Monocalcium phosphate 0.10% dl-Methionine0.02%

As provided in Table 12 below, the amount of copper meets the AAFCOrequirements and falls within the other desired nutrient, mineral, andcomponent ranges provided herein.

TABLE 12 Ingredient Amount in Food Composition Copper 8.5000 mg/kg Zinc195.2195 mg/kg  Omega-6 Fatty Acid 3.9080% Omega-3 Fatty Acid 0.5672%Taurine 2,388.495 mg/kg   DL-methionine 0.8254% Vitamin E   300 iu/kgVitamin B6 2.2500 mg/kg

Example 8

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 13 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 13 Ingredients Weight Percent of Total Composition Chicken meal16.25% Corn gluten meal 16.24% Barley 14.60% Corn 14.60% Rice 14.60%Poultry fat 10.28% Beet pulp 4.00% Natural Flavor 2.00% Dried yeast2.00% Monocalcium Phosphate 1.80% Flaxseed 1.07% Calcium carbonate 0.61%Salt 0.59% Vitamins and Minerals 0.50% Natural Preservatives 0.30%Potassium chloride 0.29% Choline chloride 0.27%

As provided in Table 14 below, the amount of copper meets the AAFCOrequirements and falls within the other desired nutrient, mineral, andcomponent ranges provided herein.

TABLE 14 Ingredient Amount in Food Composition Copper 7.4577 mg/kg Zinc186.4161 mg/kg  Omega-6 Fatty Acid 4.9159% Omega-3 Fatty Acid 0.4916%Taurine 601.2500 mg/kg  DL-methionine 0.6544% Vitamin E   300 iu/kgVitamin B6 2.2500 mg/kg

Example 9

A pet food composition was prepared by combining and mixing thefollowing ingredients provided in Table 15 at the listed amounts. Theprovided list of ingredients can be combined and/or mixed in anyparticular order and their combination is not meant to be limiting.

TABLE 15 Ingredients Weight Percent of Total Composition Pollock Meal17.22% Rice 16.62% Barley 10.00% Chicken Meal 9.80% Poultry Fat 9.76%Oats 5.20% Flaxseed 5.15% Dried Yeast 5.10% Beet Pulp 5.00% PumpkinPowder 4.00% Carrot Powder 4.00% Tomato Pomace 4.00% Natural Flavoring2.00% Salt 0.50% Vitamins and Minerals 0.50% Natural Preservatives 0.30%Lecithin 0.25% Choline chloride 0.24% Taurine 0.20% MonocalciumPhosphate 0.15% dl-Methionine 0.02%

As provided in Table 16 below, the amount of copper meets the AAFCOrequirements and falls within the other desired nutrient, mineral, andcomponent ranges provided herein.

TABLE 16 Ingredient Amount in Food Composition Copper 9.0366 mg/kg Zinc195.0081 mg/kg  Omega-6 Fatty Acid 3.7295% Omega-3 Fatty Acid 0.5818%Taurine 2,352.600 mg/kg   DL-methionine 0.8384% Vitamin E   300 iu/kgVitamin B6 2.2500 mg/kg

In some aspects, the pet food composition may include four differentcategories of ingredients. The categories include: 1) protein; 2)carbohydrate; 3) fat; and 4) micronutrients. In some aspects, theprotein may include, for example, but is not limited to beef, chicken,lamb, goat, duck, venison, pig, bison, salmon, trout, kangaroo, horse,tuna, or combinations thereof. In some aspects, the carbohydrate mayinclude, for example, but is not limited to wheat, corn, potato,lentils, various types of flour, chick peas, couscous, garbanzo beans,or combinations thereof. In some aspects, the fat may include an animaltallow, animal fat, beef tallow, chicken tallow, lamb tallow, goattallow, duck tallow, venison tallow, pig tallow, bison tallow, salmontallow, trout tallow, kangaroo tallow, horse tallow, or combinationsthereof. In some aspects, the micronutrient may be, for example, a tab,powder, mix, or liquid that provides vitamins, nutrients, and/orminerals. Depending on the desired taste, calorie values, dietaryrestrictions, or processing ability, the pet food composition may bevaried.

It will be understood that any described ingredients, processes, orsteps within the described methods may be combined with other disclosedprocesses or steps to form structures within the scope of the presentdevice. The exemplary compositions and methods disclosed herein are forillustrative purposes and are not to be construed as limiting.

It is also to be understood that variations and modifications can bemade on the aforementioned composition and disclosed methods withoutdeparting from the concepts of the present invention, and further it isto be understood that such concepts are intended to be covered by thefollowing claims unless these claims by their language expressly stateotherwise.

The above description is considered that of the illustrated embodimentsonly. Modifications of the pet food composition or methods of preparingor using it to treat pets will occur to those skilled in the art and tothose who make or use the composition. Therefore, it is understood thatthe embodiments shown in the drawings and described above is merely forillustrative purposes and not intended to limit the scope of thecomposition or methods, which is defined by the following claims asinterpreted according to the principles of patent law, including theDoctrine of Equivalents.

What is claimed is:
 1. A method of making a pet food, comprising: providing a meal base; adding at least one ingredient to provide a copper source derived from a non-chelated copper oxide to form a total copper concentration for said pet food composition from about 7.3 ppm to about 25.0 ppm; adding an omega-6 fatty acid and an omega-3 fatty acid to form a ratio between the omega-6 fatty acid and the omega-3 fatty acid from about 1:1 to about 10:1; adding a mineral; and adding a vitamin.
 2. The method of claim 1, further comprising: providing a protein ingredient selected from a group consisting of beef, chicken, lamb, goat, duck, venison, pig, bison, salmon, trout, kangaroo, horse, and tuna.
 3. The method of claim 1, further comprising: providing a carbohydrate ingredient selected from a group consisting of wheat, corn, potato, lentils, various types of flour, chick peas, couscous, and garbanzo beans.
 4. The method of claim 1, further comprising: providing a fat ingredient selected from a group consisting of animal fat, beef tallow, chicken tallow, lamb tallow, goat tallow, duck tallow, venison tallow, pig tallow, bison tallow, salmon tallow, trout tallow, kangaroo tallow, and horse tallow.
 5. The method of claim 1, wherein the total copper concentration in the pet food composition is derived from a combination of an animal by-product and at least one of a plant and a yeast.
 6. The method of claim 1, further comprising: adding DL-methionine; and adding taurine.
 7. The method of claim 1, wherein the total concentration is derived from a non-bioavailable copper.
 8. A method of forming a pet food to reduce copper accumulation in a pet, the method comprising: providing a formula selected from the group consisting of chicken, corn gluten, fish, venison, ostrich, rabbit, pea, potato, barley, rice, and corn; adding at least one ingredient having a copper source derived from a non-chelated copper oxide, and wherein the at least one ingredient forms a total copper concentration in said pet food from about 7.3 ppm to about 25.0 ppm; and adding at least one of an omega-6 fatty acid and an omega-3 fatty acid; and adding at least one mineral.
 9. The method of claim 8, wherein the step of adding at least one of an omega-6 fatty acid and an omega-3 fatty acid includes: adding each of the omega-6 fatty acid and the omega-3 fatty acid, wherein a ratio between the omega-6 fatty acid and omega-3 fatty acid ratio is from about 1:1 to about 10:1.
 10. The method of claim 8, wherein the step of adding at least one mineral includes: adding zinc oxide to form a zinc oxide concentration from about 150 mg/kg to about 1000 mg/kg.
 11. The method of claim 8, further comprising: adding a vitamin, wherein the vitamin is vitamin E; and forming a vitamin E concentration from about 300 iu/kg to about 1000 iu/kg.
 12. The method of claim 8, further comprising: adding a vitamin, wherein the vitamin is vitamin B6; and forming a vitamin B6 concentration from about 2 mg/kg to about 50 mg/kg.
 13. The method of claim 8, wherein the at least one ingredient having the copper source is selected from the group consisting of at least one of tomato pumice, flaxseed, linseed, pumpkin, carrot, field peas, chickpeas, potatoes, and beets.
 14. The method of claim 8, wherein the total copper concentration is free of copper sulfate and free of copper proteinate.
 15. The method of claim 8, wherein said pet food is free of at least one of a beef by-product and a pork by-product.
 16. The method of claim 8, further comprising: feeding a pet said pet food.
 17. A method of forming a pet food to help prevent copper storage disease in a pet, the method comprising: providing a formula having at least one formula ingredient, the at least one formula ingredient selected from the group consisting of poultry meal, corn gluten, fish, peas, potato, barley, rice, and corn; adding zinc oxide to form a zinc oxide concentration from about 150 mg/kg to about 1000 mg/kg; adding vitamin E to form a vitamin E concentration from about 300 iu/kg to about 1000 iu/kg; adding vitamin B6 to form a vitamin B6 concentration from about 2 mg/kg to about 50 mg/kg; adding at least one ingredient having a copper source derived from a non-chelated copper oxide, wherein the at least one ingredient forms a total copper concentration within said pet food from about 7.3 ppm to about 25.0 ppm.
 18. The method of claim 17, wherein the at least one ingredient having the copper source is selected from a group consisting of tomato pumice, flaxseed, linseed, pumpkin, carrot, field peas, chickpeas, potatoes, and beets.
 19. The method of claim 17, further comprising: adding an omega-6 fatty acid and an omega-3 fatty acid to reduce adverse gastrointestinal food reactions, wherein a ratio the omega-6 fatty acid to omega-3 fatty acid ratio is from about 5:1 to about 10:1.
 20. The method of claim 19, wherein said pet food is free of each of beef, dairy, and wheat ingredients to reduce food allergies. 